Adverse drug reactions observed during DOTS.

Area of Science:

• * Pharmacovigilance
• * Public Health
• * Infectious Diseases

Background:

• * Tuberculosis remains a significant global health challenge.
• * Directly Observed Treatment, Short-course (DOTS) is a key strategy for tuberculosis control under the Revised National Tuberculosis Control Programme (RNTCP).
• * Understanding adverse drug reactions (ADRs) is crucial for patient adherence and treatment success.

Purpose of the Study:

• * To determine the incidence and profile of adverse drug reactions in patients treated with DOTS.
• * To identify common ADRs and their timing during treatment.
• * To assess the impact of ADRs on treatment interruption.

Main Methods:

• * Retrospective study of 1195 patients treated between January 2002 and June 2003.
• * Detailed investigation of patients with ADRs using personal interviews and semi-structured questionnaires.
• * Analysis of ADR types, frequency, timing, and effect on treatment.

Main Results:

• * 8.37% of patients experienced adverse drug reactions.
• * Gastrointestinal reactions (53%), including nausea and vomiting, were most frequent.
• * Other common ADRs included general aches/pains (35%), giddiness (27%), skin rash/itching (17%), and arthralgia (11%). Hepatotoxicity was rare (1%).
• * Most ADRs (67%) occurred within the first four weeks of treatment.
• * Treatment interruption due to ADRs was minimal (0.25%).

Conclusions:

• * Adverse drug reactions are relatively uncommon in patients undergoing DOTS therapy for tuberculosis.
• * Gastrointestinal disturbances are the predominant ADRs, typically manifesting early in the treatment course.
• * DOTS therapy is generally well-tolerated, with minimal impact on treatment continuity.